The invention relates to a device for fixing and tensioning at least one pulling thread for applying a neovagina.
Such a device is known from the specialist article, in German, by J. Keckstein “Anlegen einer Neovagina (nach Vecchietti)” [Applying a neovagina (Vecchietti method)] in: “Die endoskopischen Operationen in der Gynäkologie” [Endoscopic operations in gynecology], publishers J. Keckstein, Hucke, Urban and Fischer Verlag 2001, 1st edition, pages 332-338. This specialist article, specifically in respect of the method described therein for applying a neovagina, is incorporated into the present application by reference.
A device of the abovementioned type is used in the context of a surgical procedure for applying a neovagina. Applying a neovagina is understood as meaning a vaginal reconstruction which is performed in the absence of a vaginal structure, the latter being a malformation of the female genitalia, as seen in Mayer-Rokitansky-Küster syndrome and in cases of testicular feminization.
The surgical procedure for vaginal reconstruction was originally performed by laparotomy and later by laparoscopy, i.e. by an endoscopic approach.
The surgical principle involved in applying a neovagina lies in stretching the vaginal dimple. A plastic olive or phantom, described in the document 36 16 957 A1 for example, and connected to two pulling threads, is used to apply continuous pressure on the vaginal dimple, and, in this way, a neovagina is stretched or formed within a period of days. The two pulling threads of the plastic olive or phantom are guided from the direction of the vaginal dimple using a straight awl, used to perforate the vaginal dimple, in the intraperitoneal direction, i.e. into the abdominal space, and then pulled with a curved awl in the retroperitoneal direction to a position in front of the abdominal wall. In front of the abdominal wall, the two pulling threads are then fixed to a device of the aforementioned type and tensioned, so that the pulling threads exert a continuous tensile force on the plastic olive or phantom, as a result of which the olive or phantom then exerts a continuous stretching pressure on the vaginal dimple.
The device known from the aforementioned specialist article in German, and used for fixing and tensioning the two pulling threads, comprises an approximately rectangular flat base body, a fixing element being arranged on each of its two narrow sides, in each case for one of the two pulling threads. Each fixing element is assigned a spring on which the corresponding pulling thread is attached. The springs have the function of attenuating sudden changes in pulling force caused by movements of the body. The two fixing elements comprise rotary screws by means of which the ends of the pulling threads are clamped and thus fixed. No tensioning of the pulling threads is permitted by way of the fixing elements, and instead the pulling threads of this device have to be tightened by hand with the rotary screw loosened, so that, before each re-tensioning, the rotary screw of the fixing element is first loosened and the pulling thread is tightened by hand, and then the rotary screw is tightened again in order to fix the pulling thread. The tensioning and fixing of the pulling threads is therefore relatively time-consuming and awkward.
In the context of the method for applying a neovagina, however, frequent re-tensioning of the pulling threads is necessary, because the plastic olive or phantom is of course intended to continuously exert pressure on the vaginal dimple and in so doing stretch the latter.
A further disadvantage of this known device is that a separate fixing element is present for each pulling thread, with the result that the two pulling threads have to be tensioned and fixed after one another and independently of one another. This not only increases the time needed for tensioning and fixing the pulling threads, but also makes it difficult to obtain uniform tensioning of the two pulling threads. Uniform tensile stressing of the two pulling threads is, however, important, because, if the tensile stressing is not uniform, only one of the pulling threads exerts a pulling force and is therefore prone to tear, and the direction of tensile force on the olive is in some cases not optimal if only one thread is pulling.
The same specialist article in German describes another device for fixing and tensioning the two pulling threads. This known device comprises two separate fixing elements, i.e. they are not arranged and secured on a common base body. Each fixing element comprises a circular base plate on which a helical spring with spaced-apart windings is arranged, this being adjoined at the top by a further circular plate on which a fixing screw is arranged for fixing a pulling thread. With these fixing elements too, the tensioning of the respective pulling thread has to be done by pulling and holding the end of the pulling thread by hand and then screwing the fixing screw tight, which, in the same way as in the known device described above, is time-consuming and awkward. In addition, this known device entails the aforementioned disadvantage that the two pulling threads cannot be tensioned simultaneously, as a result of which a uniform tensioning of the two pulling threads is likewise not possible in a controlled manner.